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High Accuracy Fecal Occult Blood Test kit, 4mm cassette, simple collection tube, proffesional use
Product Name:One Step Fecal Occult Blood Test Device
Introduction:
Many diseases may result in hidden blood in the feces. This is known as fecal occult blood (FOB), human occult blood, or human hemoglobin. In the early stages, gastrointestinal problems such as colon cancer, ulcers, polyps, colitis, diverticulitis, and fissures may not show any visible symptoms, only occult blood. Traditional guaiac based methods of occult blood testing lack sensitivity and specificity, and also require diet restrictions prior to testing. Fecal occult blood tests are used as a screening tool for detecting lower gastrointestinal (GI) bleeding that may be related to iron deficiency anemia, peptic ulcer, ulcerative colitis, polyps, and colorectal cancer. The FOB Test Device is recommended for use by health professionals in routine physical examinations and in monitoring for GI bleeding in patients in hospitals or in physicians’ offices. The Fecal Occult Blood Test is a simple, visual qualitative test that detects human hemoglobin from blood in fecal. The test is based on immunochromatography and can give a result within 5 minutes.
INTENDED USE: The Fecal Occult Blood Test Device is a qualitative test that detects human hemoglobin in human fecal specimens. The test is a visual one step, in-vitro assay. It is intended for professional use to help diagnose gastrointestinal bleeding.
Test Principle:
The Fecal Occult Blood Test is a qualitative membrane strip based immunoassay for the detection of human hemoglobin from blood in fecal. In this test procedure, anti-hemoglobin antibody is immobilized in the test line region of the device. After an adequate volume of test specimen is placed in the specimen well, it reacts with hemoglobin antibody coated particles that have been applied to the specimen pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized hemoglobin antibody. If the specimen contains hemoglobin antigen, a colored line will appear in the test line region indicating a positive result. If the specimen does not contain hemoglobin antigen, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
SPECIMEN COLLECTION AND STORAGE
1. Collect stool specimen by using the sample collection tube provided.
2. Unscrew the top of the sample collection tube, take out the sample collection stick and collect the specimen by dipping the stick into 3 different places of the stool specimen.
3. replac the stick in the sample collection tube and screw tightly.
If the specimen cannot be tested on the day of collection, store the stool specimen at 2-8. Bring the specimen to room temperature before testing.
TEST PROCEDURE
1. Bring the pouched test device to room temperature (15-30) prior to testing. Do not open the pouch until ready to perform the assay.
2. Remove the test device from the sealed pouch.
3. Specimen collection. Please see “SPECIMEN COLLECTION AND STORAGE”.
4. Shake the sample collection tube well.
5. Holding the sample collection tube upright, carefully break off the tip of collection tube.
6. Squeeze 3 drops of sample solution into the sample well “S” .
7. Read results between 5-10 minutes. Do not read results after 10 minutes.
INTERPRETATION OF RESULTS
Positive: Two colored lines appears in the result window, one in the test region and another one in the control region. This indicates a positive result no matter the test line is stronger or weaker than the control line.
Negative: Only the control line appears in the result window. This indicates a negative test result.
Invalid: If the control line does not appear, the test results are invalid regardless of the presence or absence of the test line.
NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.
PERFORMANCE CHARACTERS:
| FOB Rapid Test | |||
| Reference Test | Positive | Negative | Total |
| Positive | 76 | 0 | 76 |
| Negative | 2 | 173 | 175 |
| Total | 78 | 173 | 251 |
Relative Sensitivity: 100.0% , Relative Specificity: 98.8%, Overall Agreement: 99.2%.
